Adult Dosing
Prevention of Endometrial Hyperplasia
- Usual dose: 200 mg PO qhs x 12 days
Note:
- Given sequentially per 28-day cycle, to postmenopausal women with a uterus who are on daily therapy with conjugated estrogens
Treatment of Secondary Amenorrhea
- Usual dose: 400 mg PO qhs x 10 days
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
- An increased risk of stroke, deep vein thrombosis (DVT), pulmonary embolism, and MI has been reported with estrogen plus progestin therapy. If these events occur or are suspected, immediately discontinue estrogen plus progestin therapy. Appropriately manage risk factors for arterial vascular disease and/or venous thromboembolism, obesity and systemic lupus erythematosus
- Increased risk of stroke has been reported in women receiving daily conjugated estrogens (CE 0.625 mg) plus medroxyprogesterone acetate (MPA 2.5mg) compared to women receiving placebo
- Coronary heart disease and venous thromboembolism (VTE) have been associated with progesterone
- Discontinue treatment if venous thromboembolism (VTE) occurs
- Discontinue before surgery associated with an increased risk of thromboembolism, or during periods of prolonged immobilization
- Risk of breast cancer may increase with duration of use and appears to return to baseline in about 5 yrs after ceasing therapy. Increase in abnormal mammograms may occur; further evaluation is essential in such cases. Perform yearly breast examinations in women and advise them to perform monthly breast self-examinations. Schedule mammography examinations based on patient age, risk factors, and prior mammogram results
- Increased risk of endometrial cancer may occur with duration of use. Risk may increase 15-24 folds for 5-10 yrs or more. Risk may persist for at least 8-15 yrs after discontinuation of therapy
- Undertake adequate diagnostic measures, including endometrial sampling when needed, to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding
- Increased risk for development of ovarian cancer exists
- Dementia may occur in patients undergoing therapy with this drug
- Discontinue medication pending examination on sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia or migraine. Permanently discontinue therapy if examination reveals papilledema or retinal vascular lesions
- Increased risk of breast cancer may occur with therapy
- Fluid retention has been reported with the use of progesterone. Carefully observe patient with cardiac or renal dysfunction
- Progesterone may cause transient dizziness and drowsiness, use cautiously when driving a motor vehicle or operating machinery
Cautions: Use cautiously in
- History of liver disease
- Renal disease
- CV disease
- Hypertension
- CHF
- Dementia
- Migraine
- Diabetes mellitus
- Seizure disorder
- Sensitive to fluid retention
- History of depression
- Surgery or prolonged immobilization
- Asthma
- Hypocalcemia
- Obesity
- Elderly patients
Pregnancy Category:B
Breastfeeding: Progesterone should not be used during pregnancy. Because of the low levels of progesterone in breastmilk, even with the high-dose products, amounts ingested by the infant are small and would not be expected to cause any adverse effects in breastfed infants. Most studies indicate that progesterone is not detrimental to milk production or duration of nursing. No special precautions are required. This information is based upon Lactmed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 18 April 2011). Manufacturer advises caution.
Pricing data from www.DrugStore.com in U.S.A.
- Prometrium 100 MG CAPS [Bottle] (ABBOTT)
30 mg = $72.99
90 mg = $194.97 - Prometrium 200 MG CAPS [Bottle] (ABBOTT)
30 mg = $127
90 mg = $349.97
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
Drug Name: Prometrium 100 MG Oral Capsule
Pill Image:
[
See full size image]
Ingredient(s): Progesterone
Imprint: SV
Color(s): Orange
Shape: Round
Size (mm): 13.00
Score: 1
Inactive Ingredient(s): peanut oil / gelatin / glycerin / lecithin / titanium dioxide / d&c yellow no. 10 / fd&c red no. 40
Drug Label Author:
Solvay Pharmaceuticals, Inc.
DEA Schedule:
Non-Scheduled
Drug Name: Prometrium 200 MG Oral Capsule
Pill Image:
[
See full size image]
Ingredient(s): Progesterone
Imprint: SV2
Color(s): Yellow
Shape: Oval
Size (mm): 15.00
Score: 1
Inactive Ingredient(s): peanut oil / gelatin / glycerin / lecithin / titanium dioxide / d&c yellow no. 10 / fd&c yellow no. 6
Drug Label Author:
Solvay Pharmaceuticals, Inc.
DEA Schedule:
Non-Scheduled
65 yrs of age and invasive breast cancer has been reported with progesterone
